VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wuerzburg
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol

• Patients with measurable minimal residual disease (very good partial remission [VGPR]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study

• Patient must agree to participate in the study.

• Patient agrees to use an appropriate method of contraception.

• Willingness and ability to comply with the study protocol for the duration of the study

Exclusion Criteria:

• Patient showing signs of disease progression

• Patient has a platelet count < 100 x 10^9/L within 14 days before enrollment.

• Patient has an absolute neutrophil count < 1.0 x 10^9/L within 14 days before enrollment.

• Patient has a calculated or measured creatinine clearance < 30 mL/minute within 14 days before enrollment.

• Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment.

• Patient has hypersensitivity to bortezomib, boron, or mannitol.

• Patient has received prior treatment with bortezomib

• Patient is pregnant or nursing

• Patient has received other investigational drugs within 14 days before enrollment

• Patient has progressive disease

• Patient has a Karnofsky performance status < 60%

• Patient has a life expectancy of < 3 months

• Patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids

• Patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.